Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis

NCT05033457 · tracked via the Priya Life Science China tracker

Sponsor

Shaanxi Provincial People's Hospital

Phase

Observational

Started

2018-01-01

Last updated

2021-09-02

Condition(s) studied

Lumbar Disc Herniation

Investigational drug(s) / intervention(s)

unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy

unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy: Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.

Study summary

OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.

METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: \- Single-segment lumbar disc herniation/lumbar spinal stenosis Exclusion Criteria: * Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes Inclusion Criteria: Inclusion Criteria: Single-segment lumbar disc herniation Symptoms of nerve compression Exclusion Criteria: foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis

Primary outcome measure(s)

Cross-sectional area of the preoperative lumbar intervertebral disc — preoperative
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
Cross-sectional area of the preoperative spinal canal — preoperative
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.
Cross-sectional area of the postoperative lumbar intervertebral disc — 3 months after surgery
The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
preoperative ODI — preoperative
According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.
ODI on 3 months after operation — 3 months after surgery
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.
ODI at the final follow-up — Final follow-up
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.
preoperative VAS back pain score — preoperative
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.
preoperative VAS leg pain score — preoperative
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.
VAS back pain score on postoperative day 1 — 1 day after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.
VAS leg pain score on postoperative day 1 — 1 day after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.
VAS back pain score on 3 months after operation — 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.
VAS leg pain score on 3 months after operation — 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.
VAS back pain score at the final follow-up — Final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.
VAS leg pain score at the final follow-up — Final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.

Trial sites (1)

Facility	City	Region	Status
Shanxi Medical University	Taiyuan	Shanxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05033457 on ClinicalTrials.gov ↗ ← All trials in China